CN114305818A - Implanting instrument and assembling and disassembling tool assembly thereof - Google Patents

Abstract

The invention relates to the field of medical instruments, in particular to an implantation instrument and a loading and unloading tool assembly thereof, wherein the implantation instrument comprises a first assembly, a second assembly and a lateral connecting structure; circumferential limiting structures are arranged on the first assembly and the second assembly; the lateral connecting structure is used for axially limiting the first assembly and the second assembly. The loading and unloading tool assembly sequentially comprises a rotary operation part, a rotary force transmission part and a first guide part from the right end to the left end. According to the implant instrument and the assembling and disassembling tool assembly thereof, provided by the invention, the components of various specifications can be freely combined and repeatedly assembled and disassembled according to the actual requirements of patients, the misoperation of doctors can be avoided, and compared with similar products in the market, the implant instrument has the advantages of better safety, stronger convenience, wider adjustable range of axial distance and higher flexibility.

Description

Implanting instrument and assembling and disassembling tool assembly thereof

The invention belongs to the field of medical instruments, and particularly relates to an implanting instrument and a loading and unloading tool assembly thereof.

Background

At present, the existing medical intervention products comprise an integrated structure and a split structure, for the integrated structure, the components of the product are axially matched, the axial matching is easy to loosen in the processes of taking in a sheath tube of an implantation instrument, rotating and releasing a steel cable in the opposite direction, the operation risk is increased, in the process of matching all components of the product, repeated disassembly and assembly and individualized adjustment cannot be effectively realized, the adopted anti-loosening structure is realized by local deformation or displacement, the damage degree to the apparatus is not controllable, the product loses the original shape, and because the size of the implantation apparatus is small, local deformation or displacement in a limited space increases the difficulty of the surgical operation, the auxiliary tool is difficult to hold the implanted instrument in place, and even the adjacent components can be damaged, such anti-release structures are not adopted by the customer by local deformation or displacement, depending on the user feedback; for a split structure, the centering performance is poor in the axial assembly process of each component of the product, and the radial direction of the product protrudes, so that the income sheath process is influenced.

Patent CN112022246A provides a left atrial appendage occluder and its using method, which includes an anchoring portion, a connecting portion and a covering portion connected in sequence along an axial direction, wherein the anchoring portion includes a first supporting net and a first fixing element that can be contracted radially, the outer peripheral surface of the first supporting net is provided with a plurality of anchoring elements for grasping the tissue of the left atrial appendage, the first fixing element is detachably connected with the connecting portion, so that the anchoring portion can be separately and fixedly arranged at the left atrial appendage: the covering part comprises a second supporting net and a second fixing element which can be contracted radially, the second fixing element is arranged at one end, far away from the connecting part, of the second supporting net, and the pushing device connecting positions are respectively arranged at one ends, far away from the first supporting net, of the first fixing element and the second fixing element. According to the invention, through the specific structures and connection relations of the anchoring part, the connecting part and the covering part, the purposes that the appliance is flexible to use and the adaptability of the left auricle occluder to various forms of left auricles is improved are achieved; the following disadvantages of the patents exist: 1) The occluder in the patent has two use forms: the anchoring part is used independently or the anchoring part, the connecting part and the covering part are used in a combined mode, the plugging device is suitable for a double-disc type plugging device for the auricle with a flat shallow mouth shape clinically, and the overall height of the plugging device is limited to a certain extent; 2) the combination of anchor portion and cover portion is dismantled only to connecting portion in this patent through threaded connection's mode realization, has certain design drawback: although the assembly of each component can be realized through the rotation of the thread structure, and one embodiment of the patent realizes the mutual locking of the components through the resistance element, the difficulty is brought to the operation of repeated assembly and disassembly, for example, after the user finishes the assembly, the specification needs to be temporarily replaced, the repeated disassembly is difficult in the current design, or the disassembly resistance is large, and the operation is inconvenient; 3) in one embodiment of this patent, the connecting portion is provided with a clamping element, one end of which is rotatably mounted in a spherical cavity of the connecting portion, so as to realize the angle adjustment between the anchoring portion and the covering portion, and the design drawbacks caused by this rotatable manner mainly include: firstly, the connecting mechanism capable of rotating naturally relates to the mutual movable fit of a plurality of parts, the manufacturing difficulty is high, the rotating angle cannot be controlled accurately, after the plugging device is implanted into a human body, a user cannot accurately hold the accurate release position of the plugging device during an operation because the anchoring part and the covering part can rotate relatively, and meanwhile, the covering part is easy to shake, so that certain challenge is brought to the plugging effectiveness of the left auricle; secondly, the movable design has extremely high requirements on the fatigue performance of the occluder, and the movable connecting part can cause the risk of fatigue fracture failure along with the continuous beating of the heart after implantation; 4) in one embodiment of this patent, the connecting portion is provided with an elastic element to allow axial expansion or relative bending between the anchoring portion and the covering portion, which has the following disadvantages: the precision of axial stretching or relative bending cannot be controlled, namely the size of the axial stretching cannot be quantitatively controlled, and the stretching and stretching range is limited; 5) the connecting portion structure of this patent is complicated, especially relates to the embodiment that the hollow tube that connecting portion middle part adopted elastic metal tubular product to support, because there is great gap between the linkage unit, these gap departments probably become the source that stress corrosion takes place, influence the long-term corrosion resistance of plugging device.

Patent CN107233117B provides a left atrial appendage occluder, which comprises an occluding disk, a fixed disk and a connecting device, wherein the occluding disk is used for occluding the left atrial appendage; the fixed disk is used for fixing the left auricle occluder on the left auricle and is provided with a barb; connecting device connects shutoff dish with the fixed disk, connecting device include detachable regulation structure, detachable regulation structure include first part and with the second part that first part separates or closes, relative motion can be done to first part and second part, first part with the shutoff dish is connected, the second part with the fixed disk is connected. The depth/length of the left atrial appendage occluder can be adjusted through the relative movement between the first component and the second component, so that the left atrial appendages with different depths can be adapted; the detachable adjusting structure can be selectively connected with fixing discs with different sizes so as to adapt to left auricles with different shapes. This patent, although directed to a removable left atrial appendage occluder, still suffers from the following disadvantages: 1) the fixing discs with different sizes are detachable, and although a detachable structure is designed, an anti-falling device or a structure of the fixing disc after the fixing disc is reassembled is not designed, so that the fixing disc can be detached in the design, and potential safety hazards can be caused in actual use; 2) the height of each component of the left auricle occluder in the patent is adjusted by utilizing the relative movement of a thread structure, the reliability is not provided in the actual operation process, and the components of the occluder can rotate along with the retraction and release sheath and the traction movement of a conveying steel cable to the left auricle occluder in the operation process, so that the height adjustment is invalid, and the hidden trouble of implantation failure is brought; 3) the height adjusting piece and the plugging device are of an integrated structure, and the height adjustable range is limited; 4) in one embodiment of this patent, the length/depth of the left atrial appendage occluder can be adjusted by the insertion depth between the male spline structure and the female spline structure, or between the engaging portion and the buckling portion, but the problem of loosening after insertion is not solved.

Patent CN106466196A discloses a split type left atrial appendage plugging device, including the anchoring device and the sealed dish that the components of a whole that can function independently set up, one of anchoring device and sealed dish is equipped with the first connecting piece of tube-shape, and the other is equipped with the second connecting piece that cooperatees in order to realize dismantling the connection with the section of thick bamboo wall of first connecting piece. The first connecting piece and the second connecting piece can adopt a matching mode of a limiting hole and a hook, and can also adopt an interference fit mode simultaneously or independently. The left auricle plugging device of detachable that this patent provided can adjust anchoring device and seal interval between the dish according to the form of left auricle, makes the sealed dish can separate left atrium and left auricle completely. Adopt couple and spacing hole matched with mode, realize being connected of first connecting piece and second connecting piece, at first at the anchoring device of the suitable specification of internal release, make anchoring device fix the inside adjacent open-ended position of left auricle, then select the sealed dish of suitable specification to release, sealed dish release in-process, the couple stretches into spacing hole, when sealed dish has the trend that breaks away from left auricle, hooks spacing hole by the couple, prevents to break away from. Although this patent relates to a controllable-pitch left atrial appendage occluder, the following disadvantages still exist: 1) the connecting piece has the condition of large resistance and even sheath clamping in the process of withdrawing the sheath, so that a conveying sheath pipe with smaller sheath diameter cannot be used; 2) the connecting piece is designed by only depending on the structure that the hook is matched with the limiting hole, so that the force transmission is poor; 3) in the release of the product, the design of the barbs easily causes tangling, and even the anchoring device and the sealing disc easily fall off, so that the product cannot be released, and the design defect exists; 4) the design of the connecting piece ensures that the height adjustment precision of the connecting piece cannot be accurately ensured, and 5) the barb design of the connecting piece is easy to have fracture risk, and the barb is taken as a stress part, so that the barb can be fractured in the pushing process of a conveying system and the process of collecting and releasing a sheath of a product, and the implantation failure is caused; after the artificial bone is implanted into a human body, the barb part is easy to cause fatigue failure due to long-term stress, thereby causing fracture.

Therefore, the implantation instrument and the assembling and disassembling tool assembly thereof provided by the invention can realize free combination and repeated assembly and disassembly of components with various specifications according to the actual requirements of patients, can avoid misoperation of doctors, and have better safety, stronger convenience, wider adjustable range of axial distance and higher flexibility compared with similar products in the market.

Disclosure of Invention

In view of the above and other, it is an object of the present invention to overcome the deficiencies of the prior art.

According to an embodiment in the aspect of surgical application of the left atrial appendage occlusion device for the heart, the invention can provide an implantation instrument and a mounting and dismounting tool assembly thereof for patients with structural heart diseases and needing interventional therapy, and can solve the problems that parts of the implantation instrument with different specifications are difficult to repeatedly dismount, the dismounting resistance is large, the parts are easy to loosen, the operation is inconvenient, and the misoperation is caused, so that the safety, the convenience and the flexibility of the product are ensured.

According to one aspect of the invention, an implantation instrument includes a first component, a second component, a lateral connection structure; circumferential limiting structures are arranged on the first assembly and the second assembly; the lateral connecting structure is used for axially limiting the first assembly and the second assembly.

In one embodiment, the first component comprises a three-dimensional mesh structure and the second component comprises a scaffold structure or mesh structure.

In one embodiment, the circumferential limiting structure comprises one or more positioning bosses and positioning grooves matched with the positioning bosses.

In one embodiment, the positioning boss is non-centrally symmetric about the central axis of the implantation instrument.

In one embodiment, the locating boss is located circumferentially outward of the first assembly distal region and the locating groove is located circumferentially in the second assembly proximal region; alternatively, the circumferentially inner side of the distal region of the first component is provided with an axial slot and the axially inner side of the second component is provided with the locating boss cooperating with the axial slot.

In one embodiment, the lateral connection structure comprises a medial connection, one or more first set of lateral apertures, and a second set of lateral apertures that mate with the first set of lateral apertures; the first set of lateral apertures and the second set of lateral apertures form a radial mating zone; the radial mating area comprises a first size hole, a second size hole; the first size of the holes is different from the second size of the holes.

In one embodiment, the lateral connection structure comprises a medial connection, one or more first set of lateral apertures, and a second set of lateral apertures that mate with the first set of lateral apertures; the first set of lateral bores is axially aligned with a distal region of the first component and the second set of lateral bores is axially aligned with a proximal region of the second component; after the first assembly and the second assembly are limited by the circumferential limiting structure, the first group of lateral holes and the second group of lateral holes form radial matching areas; the middle connecting piece is communicated with and connected with the radial matching area to complete axial positioning.

In one embodiment, the distal region of the first component is a cylinder or polyhedron, the proximal region of the second component is a chamber structure matched with the cylinder or polyhedron, the cylinder or polyhedron axially passes through the chamber structure, and after circumferential positioning is achieved, the first set of lateral holes and the second set of lateral holes form a radial matching region.

In one embodiment, the intermediate connecting member is provided with an axial through hole, and the axial through hole comprises a fixed connecting part, a limiting part and a second guiding part; the limiting piece is positioned at the right end of the middle connecting piece; or, the limiting member is located between the fixed connecting portion and the second guiding member; the right end area of the radial matching area and the right end area of the fixed connecting part form a matching connecting structure, and the matching connecting structure comprises one or more combinations of threads and buckles; when the limiting part is positioned at the right end of the middle connecting piece, the limiting part tightly abuts against the right end region of the first assembly or the second assembly.

In one embodiment, when the limiting member is located between the fixed connecting portion and the second guiding member, the radial fitting region includes a first size hole and a second size hole in sequence from the right end to the left end; the aperture of the first-size hole is larger than that of the second-size hole, so that a limiting part is formed between the first-size hole and the second-size hole; the first size hole and the second size hole are through holes; or, the first size hole is a through hole, and the second size hole is a blind hole.

According to another aspect of the present invention, a loading and unloading tool assembly for an implantation instrument includes, in order from a right end to a left end, a rotation operation portion, a rotation force transmission member, and a first guide member.

In one embodiment, the rotational force transmission member is a straight structure or a cross structure.

In one embodiment, an elastic component is arranged in the rotary operation part, and when the first guide piece abuts against the left end of the blind hole, the elastic component enables the middle connecting piece to continue to move towards the left end.

In one embodiment, the left end of the first guide member is provided with an anti-falling structure, and when the middle connecting member is pre-installed on the tool assembly, the anti-falling structure prevents the middle connecting member from falling off.

In one embodiment, when the second-size hole is a through hole, the left end of the first guide member is inserted into the first-size hole from the right end to the left end and reaches the left end region or the left end region of the second-size hole, at this time, the left end of the second guide member is matched with the right end of the second-size hole, the tool assembly is operated to drive the second guide member to continue to move to the left end, and meanwhile, the rotation operation portion drives the intermediate connecting member to rotate circumferentially through the rotation force transmission member to form the matching connection structure, and then the limiting member tightly abuts against the limiting portion.

In one embodiment, when the positioning boss is located circumferentially outward of the distal region of the first component, an outermost dimension L of the positioning boss to the central axis of the implantation instrument₁Inner diameter L of said second component₂An outermost peripheral dimension L of the first component to the central axis of the implantation instrument₃The mathematical relationship is satisfied: l is₂＜ L₁≤L₃。

In one embodiment, when the second-sized hole is a through hole, the axial length L of the first guide member is greater than the axial length L of the second guide member₄Axial length L of said first size hole₅Axial length L of said second guide member₆An outer diameter D of the first guide member₁Outer diameter D of the second guide member₂An inner diameter D of the first size hole₃The inner diameter D of the second-size hole₄SaidOuter diameter D of the stopper₅The mathematical relationship is satisfied: l is₄＞L₅，L₆＞L₅；D₁＜D₂≤D₄＜D₃；D₄＜D₅＜D₃；D₃≤2D₄。

In one embodiment, when the second-sized hole is a blind hole, the axial length L of the first guide member is greater than the axial length L of the second guide member₀₁Axial length L of said first size hole₀₂Axial length L of said second guide member₀₃Axial length L of said second size hole₀₄Axial length L of said stop₀₅The mathematical relationship is satisfied: l is₀₁＋L₀₃≤L₀₄，L₀₅＜L₀₂。

In one embodiment, the tool assembly and the intermediate connecting member form a detachable connection structure by the rotational force transmission member, and a radial dimension of a left end region of the rotational operation portion decreases toward a direction approaching the first guide member.

In one embodiment, the implantation instrument comprises a first component, a second component, an intermediate connector; circumferential limiting structures which are matched with each other are arranged between the first assembly and the middle assembly and between the second assembly and the middle assembly; the first assembly and the middle assembly, the second assembly and the middle connecting piece form mutually matched lateral connecting structures, and the circumferential limiting structure and the lateral connecting structures are detachable connecting structures; after the first assembly and the middle assembly are in sliding fit or rotate circumferentially to realize quick positioning, the first assembly, the second assembly and the middle assembly are in a state to be assembled; after the tool assembly drives the middle connecting piece to be assembled with the first assembly, the second assembly and the middle assembly to form the lateral connecting structure, the middle connecting piece is partially or completely arranged in the first assembly, the second assembly or the middle assembly; the distance between the first assembly and the second assembly can be adjusted by replacing the intermediate assemblies with different height specifications.

In one embodiment, the cylindrical body and the chamber structure are both a rotating body structure.

In one embodiment, the first and second sets of lateral bores are angled with respect to a central axis of the implantation instrument.

In one embodiment, the plurality of wires of the first member converge from a proximal end to a distal end into a first connector, the distal end of the first connector being fixedly connected to the proximal end of the cylindrical body or the polyhedron.

In one embodiment, the right end area of the first size hole is provided with an internal thread, the right end area of the fixed connecting part is provided with an external thread matched with the internal thread, and the number of turns of the internal thread and the number of turns of the external thread are at least two.

In one embodiment, the rotating operation part comprises a rotating contact part, a hand-held part and a mating part in sequence from the right end to the left end; the left end region of the matching piece is of an arc-shaped structure, and the radial dimension of the matching piece is reduced towards the direction far away from the hand piece; the right end of the fixed connecting part is provided with an axial slot; the first guide piece is communicated with the axial through hole of the middle connecting piece and drives part of the rotating force transmission piece to be axially inserted into the groove, so that the rotating force transmission piece drives the middle connecting piece to rotate circumferentially.

In one embodiment, the implantation instrument comprises a first component, a second component, an intermediate connector, an intermediate component positioned between the first component and the second component; the number of the middle connecting pieces is one; the distal end region of the first component is provided with a first group of lateral holes along the axial direction, the proximal end region of the second component is provided with a second group of lateral holes along the axial direction, the proximal end region of the middle component is provided with a third group of lateral holes matched with the first group of lateral holes, and the distal end region of the middle component is provided with a fourth group of lateral holes matched with the second group of lateral holes; after the first assembly, the second assembly and the middle assembly are mutually matched, the first group of lateral holes and the third group of lateral holes are correspondingly and radially overlapped to form a first radial matching area, and the second group of lateral holes and the fourth group of lateral holes are correspondingly and radially overlapped to form a second radial matching area; the tool assembly drives the intermediate connecting piece to enter and be connected with the first radial matching area and the second radial matching area.

In one embodiment, the implantation instrument is loadable into the body through a catheter having a diameter within 14F.

In one embodiment, the wall thickness h of the chamber structure satisfies the mathematical relationship: h is more than or equal to 0.1mm and less than or equal to 0.3 mm.

In one embodiment, the intermediate connecting piece, the first assembly and the second assembly form a detachable connecting structure through threaded connection and snap connection.

In one embodiment, the left end surface or the right end surface of the middle connecting piece is an arc-shaped structure, and the arc-shaped structure forms a limiting piece.

In one embodiment, the circumferential stop structure is located at a proximal region of the lateral connection structure.

Compared with the prior art, the advantages of the invention at least comprise the following:

1. at present, most medical intervention products are of an integrated structure and a split structure, for the integrated structure, an axial matching connection mode is adopted among all components of the product, the connection mode cannot realize disassembly and personalized adjustment, the product specification among all the components cannot be effectively replaced according to the anatomical form of a patient, repeated disassembly is difficult, the occupied space of all the components is large, operation is inconvenient, all the components are easy to loosen and easy to cause misoperation of doctors, and therefore potential safety hazards are caused, for the split structure, the centering performance of all the components of the product in the axial assembly process is poor, the radial direction of the product protrudes, and the process of taking in a sheath can be influenced; circumferential limiting structures are arranged on the first assembly and the second assembly; the lateral connecting structure is used for axially limiting the first component and the second component; the loading and unloading tool assembly sequentially comprises a rotary operation part, a rotary force transmission piece and a first guide piece from the right end to the left end; simple structure, it is little that the implantation apparatus occupies sheath pipe space, can be according to patient's actual demand, realize the independent assortment and the repeated dismouting of each specification part of implantation apparatus, the dismouting is swift convenient, interference factor among the operation process has been reduced, the operation field of vision is wide, operating space is big, doctor's maloperation has been avoided, the operation security has been improved, compare like product on the market, the security is better, the convenience is stronger, the axial spacing adjustable range is wider, the flexibility is higher.

2. Different from the prior art, in one embodiment of the invention, the circumferential limiting structure comprises one or more positioning bosses and positioning grooves matched with the positioning bosses; the positioning boss is non-centrosymmetric about the central axis of the implantation instrument; the radial matching area sequentially comprises a first size hole and a second size hole from the right end to the left end; the lateral connecting structure comprises a middle connecting piece, one or more first groups of lateral holes and a second group of lateral holes matched with the first group of lateral holes; the first set of lateral apertures and the second set of lateral apertures form a radial mating zone; the radial mating area comprises a first size hole, a second size hole; the first size hole and the second size hole are different in size; the aperture of the first size hole is larger than that of the second size hole, the left end of the first guide piece is introduced into the first size hole from the right end to the left end and reaches the left end region or the left end region of the second size hole, at the moment, the left end of the second guide piece is matched with the right end of the second size hole, the tool assembly is operated to drive the second guide piece to continuously move to the left end, meanwhile, the rotating operation part drives the middle connecting piece to circumferentially rotate through the rotating force transmission piece to form the matching connection structure, and then the limiting piece is tightly abutted to the limiting part The whole process of poor problem of location effect, first guide, second guide provide the direction location effect for the intermediate junction spare loading gets into radial cooperation region, and is easy and simple to handle swift.

3. In an embodiment of the present invention, the tool assembly and the intermediate connecting member form a detachable connecting structure through the rotational force transmission member, and a radial dimension of a left end region of the rotational operation portion decreases toward a direction approaching the first guide member; and, rotatory power transmission piece is a style of calligraphy structure or cross structure, and the design both can guarantee that the operator when implanting near the operation of apparatus, avoids the instrument subassembly to touch and implants the apparatus, can guarantee again that the operator conveniently holds between the fingers assembly and disassembly tools in rotatory operation portion, avoids appearing operation error.

4. In contrast to the prior art, in an embodiment of the invention, the maximum dimension of the rotational force transmission element is smaller than the minimum peripheral dimension of the external thread; the design can guarantee that the rotary force transmission piece or the polygonal pyramid structure touches the external thread when rotating and advancing, and the possibility of failure of matching of the external thread and the internal thread is avoided.

5. Different from the prior art, in an embodiment of the invention, an elastic assembly is arranged in the rotating operation part, and when the first guide piece abuts against the left end of the blind hole, the elastic assembly enables the middle connecting piece to continuously move towards the left end along the axial direction, so that the operation is simple, convenient and rapid.

Drawings

Fig. 1a to 1d are schematic views showing the overall state of the tool assembly assembled with the implantation instrument according to one embodiment of the present invention.

Fig. 2 a-2 d are cross-sectional views of a tool assembly with an implantation instrument according to one embodiment of the present invention.

Fig. 3a to 3d are schematic diagrams illustrating a second size hole of an implantation instrument according to a second embodiment of the present invention being a blind hole.

Fig. 3e is a schematic view of a tool assembly with an elastic element according to a second embodiment of the present invention.

Fig. 4a to 4d are schematic views illustrating a process of matching the positioning boss and the positioning groove in the implantation instrument according to the first embodiment of the present invention.

Fig. 5 is a schematic view illustrating a state in which an anti-separation structure is disposed at a left end of the first guide member according to various embodiments of the present invention.

Fig. 6a to 6b are schematic views showing states of intermediate components in a third embodiment of the present invention.

Fig. 7 a-7 b are schematic views of a tool assembly with an implantation instrument according to a third embodiment of the present invention.

Fig. 7c is a schematic view of the state of the implantation instrument according to the third embodiment of the present invention.

Fig. 8a to 8b are schematic views illustrating a state where a limiting member is located between a fixed connecting portion and a second guiding member according to an embodiment of the invention.

Fig. 9a to 9c are schematic views illustrating a position-limiting element at a right end of the middle connection element according to an embodiment of the present invention.

Fig. 10a to 10c are schematic views illustrating a state where the first component includes a three-dimensional net structure and the second component includes a scaffold structure or a net structure according to a first embodiment of the present invention.

The names of the parts indicated by the numbers in the drawings are as follows: 1-an implantation instrument, 11-a first component, 111-a first set of lateral bores, 112-a cylinder, 113-a positioning boss, 114-a first connector, 12-a second component, 121-a second set of lateral bores, 122-a chamber structure, 123-a positioning recess, 13-a middle component, 131-a third set of lateral bores, 132-a fourth set of lateral bores, 2-a radial mating region, 21-a first size bore, 211-an internal thread, 22-a second size bore, 23-a stop, 24-a first radial mating region, 25-a second radial mating region, 3-a middle connector, 31-a fixation connector, 311-an external thread, 312-a slot, 32-a stop, 33-a second guide, 4-a tool component, 41-rotary operation part, 411-rotary contact part, 412-hand piece, 413-matching piece, 42-rotary force transmission piece, 43-first guide piece, 5-anti-slip structure and 6-elastic component.

Detailed Description

The invention is described in further detail below with reference to the figures and examples.

The proximal end of the invention refers to the end close to the operator along the release direction of the implantation instrument, and the distal end refers to the end far away from the operator along the release direction of the implantation instrument; in the invention, the left end refers to the left end of an operator along the release direction of the implantation instrument, and the right end refers to the right end of the operator along the release direction of the implantation instrument.

The first embodiment is as follows:

in this embodiment, as shown in fig. 1a to 1d and fig. 2a to 2d, an implantation instrument 1 comprises a first component 11, a second component 12, a lateral connection structure; a circumferential limiting structure is arranged on the first component 11 and the second component 12; the lateral connection structure is used for axially limiting the first component 11 and the second component 12.

In this embodiment, as shown in fig. 10a to 10c, the first component 11 includes a three-dimensional mesh structure, the second component 12 includes a scaffold structure or a mesh structure, the first component 11 includes a three-dimensional mesh structure, and the second component 12 includes a scaffold structure or a mesh structure.

In this embodiment, as shown in fig. 2a to 2d and fig. 4a to 4d, the circumferential limiting structure includes one or more positioning bosses 113 and positioning grooves 123 matched with the positioning bosses 113.

In this embodiment, the positioning boss 113 is non-centrosymmetric with respect to the central axis of the implantation device 1.

In this embodiment, the positioning boss 113 is located at the circumferential outer side of the distal end region of the first component 11, and the positioning groove 123 is located at the circumferential proximal end region of the second component 12.

In this embodiment, the positioning boss 113 has an outermost dimension L from the central axis of the implantation device 1₁Inner diameter L of said second component 12₂The outermost peripheral dimension L of the first component 11 to the central axis of the implantation instrument 1₃The mathematical relationship is satisfied: l is₂＜ L₁≤L₃The design can guarantee that first subassembly 11 and second subassembly 12 cooperate the in-process like this, and location boss 113 can be accurate and positioning groove 123 realize effective cooperation, and location boss 113 scrapes the sheath pipe wall when avoiding receive and release the sheath.

In this embodiment, the lateral connection structure comprises a middle connector 3, one or more first set of lateral holes 111, and a second set of lateral holes 121 that cooperate with the first set of lateral holes 111; the first and second sets of lateral holes 111, 121 form a radial mating zone 2; the radial fitting region 2 comprises a first size hole 21, a second size hole 22; the first size aperture 21 and the second size aperture 22 are of different sizes.

In this embodiment, as shown in fig. 1a to 1d, the lateral connecting structure includes a middle connecting member 3, one or more first set of lateral holes 111, and a second set of lateral holes 121 matching with the first set of lateral holes 111; the first set of lateral holes 111 is arranged axially in the distal region of the first component 11 and the second set of lateral holes 121 is arranged axially in the proximal region of the second component 12; after the first component 11 and the second component 12 are limited by the circumferential limiting structure, the first group of lateral holes 111 and the second group of lateral holes 121 form a radial matching area; the intermediate connecting piece 3 is communicated with and connected to the radial matching area 2 to complete axial positioning.

In this embodiment, as shown in fig. 1a to 1d, the distal region of the first component 11 is a cylindrical body 112, the proximal region of the second component 12 is a chamber structure 122 matched with the cylindrical body 112, and after the cylindrical body 112 axially passes through the chamber structure 122 and is circumferentially positioned, the first set of lateral holes 111 and the second set of lateral holes 121 form the radial matching region 2.

In this embodiment, as shown in fig. 1a and fig. 2a, the intermediate connecting member 3 is provided with an axial through hole, and includes a fixed connecting portion 31, a limiting member 32, and a second guiding member 33, where the limiting member 32 is located between the fixed connecting portion 31 and the second guiding member 33; the right end region of the radial matching region 2 and the right end region of the fixed connecting part 31 form a matching connecting structure, and the matching connecting structure comprises one or more combinations of threads and buckles.

In another embodiment, as shown in fig. 8a to 8b, the stopper 32 is located between the fixed connection portion 31 and the second guide 33.

In this embodiment, as shown in fig. 1b and fig. 2a, the right end region of the radial fitting region 2 is provided with an internal thread 211, the right end region of the fixed connection portion 31 is provided with an external thread 311 fitted with the internal thread 211, and the number of turns of the internal thread 211 and the number of turns of the external thread 311 are at least two.

In another embodiment, as shown in fig. 9a to 9c, the intermediate connecting member 3 is provided with an axial through hole, which includes a fixing connecting portion 31, a limiting member 32, and a second guiding member 33, wherein the limiting member 32 is located at the right end of the intermediate connecting member 3, and the limiting member 32 abuts against the right end region of the second component 12.

In this embodiment, as shown in fig. 1a to 1d, the tool assembly 4 includes a rotation operation portion 41, a rotation force transmission member 42, and a first guide member 43 in sequence from a right end to a left end, the tool assembly 4 and the intermediate connection member 3 form a detachable connection structure through the rotation force transmission member 42, and a radial dimension of a left end region of the rotation operation portion 41 decreases toward a direction close to the first guide member 43; the rotational force transmission member 42 has a straight-line structure.

In this embodiment, as shown in fig. 1a to 1d, the rotary operation part 41 includes a rotary contact element 411, a hand-held element 412, and a mating element 413 in sequence from the right end to the left end; the left end region of the fitting piece 413 is an arc-shaped structure, and the radial dimension of the arc-shaped structure is reduced towards the direction far away from the hand piece 412; the right end of the fixed connecting part 31 is provided with an axial slot 312; the first guiding element 43 passes through the axial through hole of the intermediate connecting element 3 and drives a part of the rotational force transmission element 42 to axially insert into the slot 312, so that the rotational force transmission element 42 drives the intermediate connecting element 3 to circumferentially rotate.

In this embodiment, as shown in fig. 1a, when the limiting member 32 is located between the fixed connecting portion 31 and the second guiding member 33, the radial matching area 2 sequentially includes a first size hole 21 and a second size hole 22 from the right end to the left end; the aperture of the first-size hole 21 is larger than that of the second-size hole 22, so that a limiting part 23 is formed between the first-size hole 21 and the second-size hole 22; the first size hole 21 and the second size hole 22 are through holes.

In this embodiment, as shown in fig. 2a to 2d, when the second-size hole 22 is an axial through hole, the first guide 4 isThe left end of the middle connecting member 3 is led into the first size hole 21 from the right end to the left end under the driving of the tool assembly 4 and reaches the left end region or the left end region of the second size hole 22, at this time, the left end of the second guiding member 33 is matched with the right end of the second size hole 22, the tool assembly 4 is operated to drive the second guiding member 33 to continuously move to the left end, meanwhile, the rotating operation part 41 drives the middle connecting member 3 to circumferentially rotate through the rotating force transmission member 42 to form the matching connecting structure, and then the limiting part 32 tightly abuts against the limiting part 23; wherein the axial length L of the first guide 43₄Axial length L of said first size hole 21₅The axial length L of the second guide member 33₆Outer diameter D of the first guide member 43₁Outer diameter D of the second guide member 33₂Inner diameter D of said first size hole 21₃Inner diameter D of said second size hole 22₄The outer diameter D of the limiting member 32₅The mathematical relationship is satisfied: l is₄＞L₅，L₆＞L₅；D₁＜D₂≤D₄＜D₃；D₄＜D₅＜D₃；D₃≤2D₄。

In this embodiment, as shown in fig. 5, the left end of the first guiding element 43 is provided with a retaining structure 5, and when the intermediate connecting element 3 is pre-installed on the tool assembly 4, the retaining structure 5 prevents the intermediate connecting element 3 from falling off.

In this embodiment, the cylindrical body 112 and the chamber structure 122 are both of a rotating body structure.

In this embodiment, the first and second sets of lateral holes 111, 121 are angled with respect to the central axis of the implantation device 1.

In this embodiment, the plurality of wires of the first assembly 11 are converged into a first connecting member 114 from the proximal end to the distal end, and the distal end of the first connecting member 114 is fixedly connected to the proximal end of the cylindrical body 112.

In this embodiment, the implantation instrument 1 can be loaded into the body through a catheter having a diameter within 14F.

In this embodiment, the wall thickness h of the chamber structure 122 satisfies the mathematical relationship: h is more than or equal to 0.1mm and less than or equal to 0.3 mm.

In this embodiment, when the tool assembly 4 is assembled with the implantation instrument 1, as shown in fig. 1b, the circumferential stop is located in the proximal region of the lateral connection.

Example two:

the difference from the first embodiment is that:

in this embodiment, as shown in fig. 3a to 3d, the first size hole 21 is a through hole, and the second size hole 22 is an axial blind hole.

In this embodiment, as shown in fig. 3a to 3d, when the second-size hole 22 is an axial blind hole, and the tool assembly 4 drives the intermediate connecting member 3 to enter and connect to the radial mating region 2, the distal end of the first guiding member 43 passes through the first-size hole 21 and reaches the proximal end of the second-size hole 22; wherein the axial length L of the first guide 43₀₁Axial length L of said first size hole 21₀₂The axial length L of the second guide member 33₀₃Axial length L of said second size hole 22₀₄Axial length L of the limiting member 32₀₅The mathematical relationship is satisfied: l is₀₁＋L₀₃≤L₀₄，L₀₅＜L₀₂。

In this embodiment, as shown in fig. 3e, an elastic component 6 is disposed in the rotating operation portion 41, and when the first guide 43 abuts against the left end of the blind hole, the elastic component 6 makes the intermediate connecting member 3 move to the left end in the axial direction.

Example three:

the difference from the first embodiment is that:

in this embodiment, as shown in fig. 6a to 6b and fig. 7a to 7c, a quick and repeated detachable implantation apparatus 1 and a tool assembly 4 thereof include an implantation apparatus 1 and a tool assembly 4 for repeatedly detaching and attaching the implantation apparatus 1, wherein the implantation apparatus 1 includes a first assembly 11, a second assembly 12, an intermediate assembly 13, and an intermediate connecting member 3; circumferential limiting structures which are matched with each other are arranged between the first component 11 and the middle component 13 and between the second component 12 and the middle component 13; the first component 11 and the middle component 13, and the second component 12 and the middle component 13 and the middle connecting piece 3 form mutually matched lateral connecting structures, and the circumferential limiting structure and the lateral connecting structures are detachable connecting structures; after the first assembly 11 and the intermediate assembly 13, and the second assembly 12 and the intermediate assembly 13 are in sliding fit or rotate circumferentially to realize quick positioning, the first assembly 11, the second assembly 12 and the intermediate assembly 13 are in a state to be assembled; after the tool component 4 drives the middle connecting piece 3 to be assembled with the first component 11, the second component 12 and the middle component 13 to form the lateral connecting structure, part or all of the middle connecting piece 3 is arranged in the first component 11, the second component 12 or the middle component 13.

In this embodiment, as shown in fig. 6a to 6b and fig. 7a to 7c, the implantation instrument 1 comprises a first component 11, a second component 12, an intermediate connector 3, an intermediate component 13 located between the first component 11 and the second component 12; the number of the intermediate connecting pieces 3 is one; the distal end area of the first component 11 is provided with a first set of lateral holes 111 along the axial direction, the proximal end area of the second component 12 is provided with a second set of lateral holes 121 along the axial direction, the proximal end area of the middle component 13 is provided with a third set of lateral holes 131 matched with the first set of lateral holes 111, and the distal end area of the middle component 13 is provided with a fourth set of lateral holes 132 matched with the second set of lateral holes 121; after the first component 11, the second component 12 and the middle component 13 are fitted with each other, the first set of lateral holes 111 and the third set of lateral holes 131 are correspondingly radially overlapped to form a first radial fitting region 24, and the second set of lateral holes 121 and the fourth set of lateral holes 132 are correspondingly radially overlapped to form a second radial fitting region 25; the tool assembly 4 drives the intermediate connecting element 3 into and into the first radial engagement area 24 and into the second radial engagement area 25.

The foregoing is only an exemplary embodiment of the present invention, and those skilled in the art can change the invention in its specific embodiments and application scope according to the spirit of the present invention, and the present specification should not be construed as limiting the invention.

Claims (15)

1. An implantation instrument comprising a first component, a second component, a lateral connection structure; the method is characterized in that: circumferential limiting structures are arranged on the first assembly and the second assembly; the lateral connecting structure is used for axially limiting the first assembly and the second assembly.

2. An implantation instrument as defined in claim 1, wherein: the first component comprises a three-dimensional net structure, and the second component comprises a stent structure or a net structure.

3. An implantation instrument as defined in claim 1, wherein: the circumferential limiting structure comprises one or more positioning bosses and positioning grooves matched with the positioning bosses.

4. An implantation instrument as defined in claim 3, wherein: the positioning boss is non-centrosymmetric about the central axis of the implantation instrument.

5. An implantation instrument as defined in claim 3, wherein: the locating boss is located circumferentially outward of the first assembly distal region, and the locating groove is located circumferentially in the second assembly proximal region; alternatively, the circumferentially inner side of the distal region of the first component is provided with an axial slot and the axially inner side of the second component is provided with the locating boss cooperating with the axial slot.

6. An implantation instrument as claimed in any one of claims 1 to 5, wherein: the lateral connecting structure comprises a middle connecting piece, one or more first groups of lateral holes and a second group of lateral holes matched with the first group of lateral holes; the first set of lateral apertures and the second set of lateral apertures form a radial mating zone; the radial mating area comprises a first size hole, a second size hole; the first size of the holes is different from the second size of the holes.

7. An implantation instrument as defined in claim 6, wherein: the first set of lateral bores is axially aligned with a distal region of the first component and the second set of lateral bores is axially aligned with a proximal region of the second component; after the first assembly and the second assembly are limited by the circumferential limiting structure, the first group of lateral holes and the second group of lateral holes form radial matching areas; the middle connecting piece is communicated with and connected with the radial matching area to complete axial positioning.

8. An implantation instrument as defined in claim 1, wherein: the far-end region of the first assembly is a cylindrical body or a polyhedron, the near-end region of the second assembly is a chamber structure matched with the cylindrical body or the polyhedron, and the cylindrical body or the polyhedron axially passes through the chamber structure and is circumferentially positioned.

9. An implantation instrument as defined in claim 6, wherein: the middle connecting piece is provided with an axial through hole and comprises a fixed connecting part, a limiting piece and a second guide piece; the limiting piece is positioned at the right end of the middle connecting piece; or, the limiting member is located between the fixed connecting portion and the second guiding member; the right end area of the radial matching area and the right end area of the fixed connecting part form a matching connecting structure, and the matching connecting structure comprises one or more combinations of threads and buckles; when the limiting part is positioned at the right end of the middle connecting piece, the limiting part tightly abuts against the right end region of the first assembly or the second assembly.

10. An implantation instrument as defined in claim 9, wherein: when the limiting part is positioned between the fixed connecting part and the second guide part, the radial matching area sequentially comprises a first size hole and a second size hole from the right end to the left end; the aperture of the first-size hole is larger than that of the second-size hole, so that a limiting part is formed between the first-size hole and the second-size hole; the first size hole and the second size hole are through holes; or, the first size hole is a through hole, and the second size hole is a blind hole.

11. A handling tool assembly for use with the implantation instrument of any of claims 1-10, wherein: the tool assembly comprises a rotary operation part, a rotary force transmission part and a first guide part from the right end to the left end in sequence.

12. The loading and unloading tool assembly of the implantation instrument of claim 11, wherein: the rotating force transmission piece is of a straight-line structure or a cross-shaped structure.

13. The loading and unloading tool assembly of the implantation instrument of claim 11, wherein: an elastic assembly is arranged in the rotary operation part, and when the first guide piece abuts against the left end of the blind hole, the elastic assembly enables the middle connecting piece to continue to move towards the left end.

14. The loading and unloading tool assembly of the implantation instrument of claim 11, wherein: first guide left end is equipped with anti-disengaging structure, the intermediate junction spare is adorned in advance when on the instrument subassembly, anti-disengaging structure prevents the intermediate junction spare drops.

15. The loading and unloading tool assembly of the implantation instrument of claim 11, wherein: when the second-size hole is a through hole, the left end of the first guide piece is introduced into the first-size hole from the right end to the left end and reaches the left end region or the left end region of the second-size hole, at the moment, the left end of the second guide piece is matched with the right end of the second-size hole, the tool assembly is operated to drive the second guide piece to continue to move to the left end, meanwhile, the rotating operation portion drives the middle connecting piece to rotate circumferentially through the rotating force transmission piece to form the matching connection structure, and then the limiting piece tightly abuts against the limiting portion.

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